OR3O Dual Mobility 71358251

GUDID 00885556800843

OR3O DUAL MOBILITY LINER 32/44

Smith & Nephew, Inc.

Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner
Primary Device ID00885556800843
NIH Device Record Keyec91c00c-350d-477d-b779-40f2ed8db86e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOR3O Dual Mobility
Version Model Number71358251
Catalog Number71358251
Company DUNS109903521
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556800843 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-07
Device Publish Date2022-08-30

On-Brand Devices [OR3O Dual Mobility]

00885556710661OR3O DUAL MOBILITY TRIAL INSERT 28/54
00885556710654OR3O DUAL MOBILITY TRIAL INSERT 28/52
00885556710647OR3O DUAL MOBILITY TRIAL INSERT 28/50
00885556710630OR3O DUAL MOBILITY TRIAL INSERT 28/48
00885556710623OR3O DUAL MOBILITY TRIAL INSERT 28/46
00885556710616OR3O DUAL MOBILITY TRIAL INSERT 28/44
00885556710609OR3O DUAL MOBILITY TRIAL INSERT 28/42
00885556710586OR3O DUAL MOBILITY TRIAL INSERT 22/40
00885556710562OR3O DUAL MOBILITY TRIAL INSERT 22/38
00885556710555OR3O DUAL MOBILITY TRIAL INSERT 22/36
00885556712429OR3O DUAL MOBILITY XLPE INSERT 28/52
00885556712412OR3O DUAL MOBILITY XLPE INSERT 28/50
00885556712405OR3O DUAL MOBILITY XLPE INSERT 28/48
00885556712399OR3O DUAL MOBILITY XLPE INSERT 28/46
00885556712382OR3O DUAL MOBILITY XLPE INSERT 28/44
00885556712375OR3O DUAL MOBILITY XLPE INSERT 28/42
00885556712351OR3O DUAL MOBILITY XLPE INSERT 22/40
00885556712344OR3O DUAL MOBILITY XLPE INSERT 22/38
00885556712337OR3O DUAL MOBILITY XLPE INSERT 22/36
00885556712313OR3O DUAL MOBILITY LINER 52/66-70
00885556712306OR3O DUAL MOBILITY LINER 50/64
00885556712290OR3O DUAL MOBILITY LINER 48/62
00885556712283OR3O DUAL MOBILITY LINER 46/60
00885556712276OR3O DUAL MOBILITY LINER 44/58
00885556712269OR3O DUAL MOBILITY LINER 44/56
00885556712252OR3O DUAL MOBILITY LINER 42/54
00885556712245OR3O DUAL MOBILITY LINER 40/52
00885556712238OR3O DUAL MOBILITY LINER 38/50
00885556712221OR3O DUAL MOBILITY LINER 36/48
00885556710548OR3O DUAL MOBILITY TRIAL LINER 54/72-74
00885556710531OR3O DUAL MOBILITY TRIAL LINER 52/66-70
00885556710524OR3O DUAL MOBILITY TRIAL LINER 50/64
00885556710517OR3O DUAL MOBILITY TRIAL LINER 48/62
00885556710500OR3O DUAL MOBILITY TRIAL LINER 46/60
00885556710494OR3O DUAL MOBILITY TRIAL LINER 44/58
00885556710487OR3O DUAL MOBILITY TRIAL LINER 44/56
00885556710470OR3O DUAL MOBILITY TRIAL LINER 42/54
00885556710463OR3O DUAL MOBILITY TRIAL LINER 40/52
00885556710456OR3O DUAL MOBILITY TRIAL LINER 38/50
00885556710449OR3O DUAL MOBILITY TRIAL LINER 36/48
00885556712320OR3O DUAL MOBILITY LINER 54/72-74
00885556800874OR3O DUAL MOBILITY XLPE INSERT 22/34
00885556800867OR3O DUAL MOBILITY XLPE INSERT 22/32
00885556800850OR3O DUAL MOBILITY LINER 34/46
00885556800843OR3O DUAL MOBILITY LINER 32/44
00885556724897OR3O DUAL MOBILITY XLPE INSERT 28/38
00885556712368OR3O DUAL MOBILITY XLPE INSERT 28/40
00885556800911OR3O DUAL MOBILITY TRIAL LINER 32/44
00885556800904OR3O DUAL MOBILITY TRIAL LINER 34/46
00885556800898OR3O DUAL MOBILITY TRIAL INSERT 22/32

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.